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Light-assisted drying (LAD) is a new optical processing technique for forming trehalose amorphous solids to preserve biologics, while avoiding the freezing step necessary for lyophilisation.
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
During monoclonal antibody (mAb) manufacture, continuous flowsheets could offer ~20 percent–40 percent cost of goods (COG) saving over the batch process, for instance, during low commercial demand, a paper suggests.
Model Predictive Control (MPC) “stands out as a beacon of advanced control” in continuous manufacturing, through its ability to enhance efficacy within bioproduction, research suggests.
An ultra-high sensitivity and super-resolution infrared imaging technique for single proteins could lead the way to a multitude of applications using infrared nanospectroscopy.
The biologic is approved based on Phase III study data in generalised myasthenia gravis (gMG), which demonstrated that rozanolixizumab facilitated statistically significant improvements in gMG-specific outcomes compared to placebo.
In this article, Dr Michael Flanagan discusses how a new class of medicines called antibody oligonucleotide conjugates (AOCs) have the potential to overcome a major challenge encountered with many established RNA-based therapeutics: delivery to tissues outside the liver. Last year, AOCs demonstrated the first-ever successful targeted delivery of RNA into…
Through a new acquisition, Boehringer Ingelheim will have rights to a platform that enables the design of immuno-oncology combination therapies in one single agent.
The first pill designed to directly block calcitonin gene-related peptide (CGRP), a protein released during a migraine attack, has demonstrated positive evidence in AbbVie’s trial investigating its efficacy in the prodrome phase.
The European Commission has authorised the first protein-based adapted vaccine for COVID-19.
This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
12 October 2023 | By Thermo Fisher Scientific (Patheon)
HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
Here, Chief Scientist Bruce Lahn of the CDMO VectorBuilder discusses best practices, common problems, and possible solutions to mitigate risk and free up capacity when developing and designing mRNA therapeutics.
In this article, Gareth Morgan, a life sciences partner at Pinsent Masons discusses how Leqembi validates the anti-amyloid approach for treating Alzheimer’s, and whether its recent regulatory authorisations could support fast-tracking approvals of other promising Alzheimer’s therapies.
